Data Mining as A Service in Medical DevicesEMMAIntl
Data mining is the field of Computer Science that forms the basis for data analytics. As the term specifies, it is utilized for ‘mining’ or extracting the most significant data from ‘Big Data’ or massive data sets. It not only serves as an extraction tool but also assists manufacturers and researchers in deriving hypotheses or conclusions from the existing Big Data sets, which can be applied toward improving existing services. Even though Data Mining is extensively utilized in commercial domains such as e-commerce or finance, it is indeed also proving to be vital for improving services in the health care domain. When utilized for developing or enhancing medical services, manufacturers should make sure their mining tool is safe and qualified enough to be integrated with medical devices...
HXR 2016: Free the Data Access & Integration -Peter Levin, Amida Technology S...HxRefactored
Utilizing the power of data can empower patients and arm developers in the creation of new tools and platforms. Whether it’s authenticating data, downloading it via BlueButton, or connecting data with other applications using BlueButton on FHIR, increased data accessibility is a win for everyone. Presenters will give an overview of the opportunities and challenges that exist today and share the newest technologies and initiatives that are overcoming them.
Data Mining as A Service in Medical DevicesEMMAIntl
Data mining is the field of Computer Science that forms the basis for data analytics. As the term specifies, it is utilized for ‘mining’ or extracting the most significant data from ‘Big Data’ or massive data sets. It not only serves as an extraction tool but also assists manufacturers and researchers in deriving hypotheses or conclusions from the existing Big Data sets, which can be applied toward improving existing services. Even though Data Mining is extensively utilized in commercial domains such as e-commerce or finance, it is indeed also proving to be vital for improving services in the health care domain. When utilized for developing or enhancing medical services, manufacturers should make sure their mining tool is safe and qualified enough to be integrated with medical devices...
HXR 2016: Free the Data Access & Integration -Peter Levin, Amida Technology S...HxRefactored
Utilizing the power of data can empower patients and arm developers in the creation of new tools and platforms. Whether it’s authenticating data, downloading it via BlueButton, or connecting data with other applications using BlueButton on FHIR, increased data accessibility is a win for everyone. Presenters will give an overview of the opportunities and challenges that exist today and share the newest technologies and initiatives that are overcoming them.
Aneesh Chopra - HealthCa.mp/dev Keynote. 2016: the Year to participate in the...Mark Scrimshire
On Saturday May7th, Aneesh Chopra gave a Keynote Address at HealthCa.mp/dev. This is the year to engage in the FHIR API and the FHIR Community to push HealthCare interoperability forward.
Replicating the FDA MAUDE DB for September 2021 in order to search MDR summaries as well as create custom insights. Required downloading files from the FDA, using python to confirm data structure, and upload to database tables. WAMP stack used to access data/provide charts.
CMS BlueButton On FHIR for Researchers - Presentation to NIH and PCORI Resear...Mark Scrimshire
This is a presentation given to researchers from PCORI and NIH (Precision Medicine Initiative) about the potential benefits to researchers that comes from letting CMS Medicare Beneficiaries share their Claims information with a research study using the Proposed CMS BlueButton data formats built on the HL7 Fast Health Interoperability Resources Specification.
From Edge Case to Main Case, Michelle Longmire of Medable_mHealth IsraelLevi Shapiro
Presentation by Michelle Longmire, CEO of Medable, April 20, 2021, for mHealth Israel. During CoVID, as physical access to clinics was limited, Medable enabled patients to continue participating in critical research efforts. Medable Supporting over 100 Studies Across a Diverse Array of Therapeutic Areas. Medable provides a platform for seamless evidence
generation, across the entire patient journey. Connecting patients globally for community, care, and research. Improve patient experience and retention. Reduce site burden. Data Cloud & Platform should be flexible and modular to enable protocol-fit digital. Medable Digitome, for data driven decentralized trials and a new era of understanding patients, therapies, and conditions. Clinical research is a small component of the broader healthcare journey. Enable health data and evidence generation from clinical to commercial, from day one. Continuous health data & evidence from clinical to commercial and beyond. The Digitome can provide a
primary observational protocol that collects large scale baseline data in a framework that enables streamlined recruitment, enrollment, and participation into interventional clinical substudies.
Healthcare Data Quality & Monitoring PlaybookCitiusTech
The healthcare industry has made significant strides across the care continuum, but incomplete and poor data quality still remains a challenge. In this brief playbook, we share key challenges, important quality checks, and a 4 step approach to enhance data quality.
Brisbane Health-y Data: Queensland Data Linkage FrameworkARDC
Presentation given by Trisha Johnston and Catherine Taylor at the 'Sharing Health-y Data Workshop: Challenges and Solutions' event co-hosted by ANDS and HISA. Held on Wednesday 16th March 2016 at the Translational Research Institute, Brisbane, Australia.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Patientory and its Role in Clinical Trials TransparencyPatientory
Patientory.com. Discover how Patientory as SaaS (Software as a Service) can overcome the challenges of clinical trials transparency and recruitment.
Your Health, at your fingertips. Visit Now Patientory.com.
AMM January Meeting presentation by John Kamp, Executive Director, Coalition for Healthcare Communication: "The Current Regulatory and Political Landscape of Pharmaceutical Marketing & Education"
Aneesh Chopra - HealthCa.mp/dev Keynote. 2016: the Year to participate in the...Mark Scrimshire
On Saturday May7th, Aneesh Chopra gave a Keynote Address at HealthCa.mp/dev. This is the year to engage in the FHIR API and the FHIR Community to push HealthCare interoperability forward.
Replicating the FDA MAUDE DB for September 2021 in order to search MDR summaries as well as create custom insights. Required downloading files from the FDA, using python to confirm data structure, and upload to database tables. WAMP stack used to access data/provide charts.
CMS BlueButton On FHIR for Researchers - Presentation to NIH and PCORI Resear...Mark Scrimshire
This is a presentation given to researchers from PCORI and NIH (Precision Medicine Initiative) about the potential benefits to researchers that comes from letting CMS Medicare Beneficiaries share their Claims information with a research study using the Proposed CMS BlueButton data formats built on the HL7 Fast Health Interoperability Resources Specification.
From Edge Case to Main Case, Michelle Longmire of Medable_mHealth IsraelLevi Shapiro
Presentation by Michelle Longmire, CEO of Medable, April 20, 2021, for mHealth Israel. During CoVID, as physical access to clinics was limited, Medable enabled patients to continue participating in critical research efforts. Medable Supporting over 100 Studies Across a Diverse Array of Therapeutic Areas. Medable provides a platform for seamless evidence
generation, across the entire patient journey. Connecting patients globally for community, care, and research. Improve patient experience and retention. Reduce site burden. Data Cloud & Platform should be flexible and modular to enable protocol-fit digital. Medable Digitome, for data driven decentralized trials and a new era of understanding patients, therapies, and conditions. Clinical research is a small component of the broader healthcare journey. Enable health data and evidence generation from clinical to commercial, from day one. Continuous health data & evidence from clinical to commercial and beyond. The Digitome can provide a
primary observational protocol that collects large scale baseline data in a framework that enables streamlined recruitment, enrollment, and participation into interventional clinical substudies.
Healthcare Data Quality & Monitoring PlaybookCitiusTech
The healthcare industry has made significant strides across the care continuum, but incomplete and poor data quality still remains a challenge. In this brief playbook, we share key challenges, important quality checks, and a 4 step approach to enhance data quality.
Brisbane Health-y Data: Queensland Data Linkage FrameworkARDC
Presentation given by Trisha Johnston and Catherine Taylor at the 'Sharing Health-y Data Workshop: Challenges and Solutions' event co-hosted by ANDS and HISA. Held on Wednesday 16th March 2016 at the Translational Research Institute, Brisbane, Australia.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Patientory and its Role in Clinical Trials TransparencyPatientory
Patientory.com. Discover how Patientory as SaaS (Software as a Service) can overcome the challenges of clinical trials transparency and recruitment.
Your Health, at your fingertips. Visit Now Patientory.com.
AMM January Meeting presentation by John Kamp, Executive Director, Coalition for Healthcare Communication: "The Current Regulatory and Political Landscape of Pharmaceutical Marketing & Education"
Pharmacogenomics in Clinical Medicine: What Is FDA Doing to Facilitate the M...Ryan Squire
Larry Lesko, director of the Office of Clinical Pharmacology at the Center for Drug Evaluation and Research with the Federal Drug Administration, begins his talk by making the FDA’s commitment to personalized medicine as a public health agency. He touched on the future focus of improving drug safety and its role in future healthcare policy, citing the FDA Amendments Act of 2007.
Lesko explained that the dual mission at hand is to foster innovation and promote new initiatives under a critical path while developing and clearly articulating the standards for drugs and diagnostics. The organization takes a lifecycle approach to evidence to inform and support decisions—this goes for previous drugs and new drug development.
Moving forward, what else needs to be done? Lesko explained that ways to consensus on evidence are needed to support new drug approvals and relabeling of older drugs. He also believes that the FDA needs to develop more unambiguous drug product labels to enable actionable medical decisions and improve communication between CDER and CDRH on co-development and companion diagnostics.
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Addressing Privacy and Security Concerns to Unlock Insights in Big Data in He...Health Data Consortium
Watch the webinar here: http://www.screencast.com/t/6E1ZgTOb
Deven McGraw, Partner at Manatt, Phelps & Phillips, discussed privacy and security concerns in regards to the liberation and usage of health data. There is enormous potential to glean valuable insights from large data sets of health (and health-related) information - but the collection and use of health information for analytics purposes raises privacy and security concerns. Solution of these issues is key to realizing the benefits of health big data. This presentation will focus primarily on some of the regulatory challenges to learning uses of clinical and administrative claims data but also touch on challenges to big data analytics in other contexts (for example, government data and data collected by consumer-facing commercial entities like mobile health apps, social networking sites, search engines, and other personal health tools).
Discover more health data resources on our website at http://www.healthdataconsortium.org/
Challenges and Opportunities Around Integration of Clinical Trials DataCitiusTech
Conducting a Clinical Trial is a complex process, consisting of activities such as protocol preparation, site selection, approval of various authorities, meticulous collection and management of data, analysis and reporting of the data collected
Each activity is benefited from the development of point applications which ease the process of data collection, reporting and decision making. The recent advancements in mobile technologies and connectivity has enabled the generation and exchange of a lot more data than previously anticipated. However, the lack of interoperability and proper planning to leverage this data, still acts as a roadblock in allowing organizations truly harness their data assets. This document will help life sciences IT professionals and decision makers understand challenges and opportunities around clinical data integration
21st Century Act and its Impact on Healthcare ITCitiusTech
This document gives an overview, core objectives of the act and enumerates purpose of each part / division of the 21st Century Act. It lists down the sections of the act which have a direct impact on Healthcare IT and gives a brief overview of each section.This document also explains the impact of 21st Century Cures Act on regulatory bodies: FDA / NIH / HSS.
Data Privacy and Security in Clinical Trials: Safeguarding Patient InformationClinosolIndia
Data privacy and security in clinical trials are critical to safeguard patient information and ensure compliance with relevant regulations, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States and the General Data Protection Regulation (GDPR) in the European Union.
iHT2 Health IT Summit in Austin 2012 – Deborah C. Peel, MD, Founder and Chair, Patient Privacy Rights, ase Study “Considerations and Opportunities: Will Digital Health Data and Patient Altruism Transform Healthcare Research?”
Health IT Data Security – An Overview of Privacy, Compliance, and Technology ...M2SYS Technology
Radical advancements in health IT development and implementation have pushed the issue of health data security to the forefront of the collective healthcare provider mindset as they attempt to strike a balance between patient access to electronic health record protected health information (PHI) and data protection. The fact that so many health IT vendors now have access to and possess protected health information necessitated shift changes in the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which was enacted to establish ground rules for the privacy protection of individually identifiable health information.
We invited Mac McMillan, Chair of the HIMSS Privacy and Security Task Force to discuss what these new changes are, define their parameters, the mission of the HIMSS PRivacy & Security Task Force, his definition of what “privacy” actually is, comments on new technology that are viable options for healthcare providers to implement as a way to protect access to sensitive patient data, and his thoughts on the increased adoption of PHI management applications such as Microsoft HealthVault.
Listen in to this podcast for more information on the latest health IT industry developments and regulations that govern PHI and for insight from Mac on why healthcare providers and third party vendors should pay close attention to compliance with recent HIPAA changes.
Accelerating Patient Care with Real World EvidenceCitiusTech
Life sciences and pharma companies are evolving their strategies to utilize Real World Data (RWD) to demonstrate value of pharmaceutical and medical device innovations. Technology advancements at the point of care and improvements in data collection strategies have led to a significant increase in the availability of RWD in healthcare
Real World Evidence (RWE) can provide actionable patient insights and accelerates time to market of new medical products in order to gain competitive advantage
With the emergence of wearable technologies, Internet of Things (IOT), Cognitive Computing, Genomics, Blockchain, etc., future RWE data sources will become more diverse and extensive. This document introduces the concept of Real World Evidence studies in healthcare, describes the various data sources for performing real world analytics and illustrates the role of RWE in better patient care. It then summarizes challenges faced while performing RWE analytics with respect to regulatory compliance, data accessibility and sharing, analysis reporting, costs etc.
January 23, 2017
The Fifth Annual Health Law Year in P/Review symposium featured leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event covered hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.
The Fifth Annual Health Law Year in P/Review was sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/5th-annual-health-law-year-in-p-review
Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016.
This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.
Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.
Legal barriers to better use of health data to deliver pharmaceutical innovationOffice of Health Economics
The range of data sources and technologies relevant to pharmaceutical R&D continues to expand. In this presentation, I summarise research evaluating the main legal barriers to the better use of health data for pharmaceutical innovation, concluding that the General Data Protection Regulation (GDPR) does not create new legal barriers, and that most issues identified are in fact uncertainties rather than barriers per se. There is a strong case for industry to deal proactively with the uncertainties, sharing good practice, engendering trust and promoting a shared understanding of the value to society of pharmaceutical research.
Author(s) and affiliation(s): Amanda Cole, Office of Health Economics.
Event: CPDP 2019: Computers, Privacy and Data Protection conference
Date: 01/02/2019
Location: Brussels, Belgium
This module describes how missing data can be managed while maintaining data quality. It explains how to plan for missing data; defines different types of “missingness;” outlines the benefits of documenting missing data and illustrates how to document missing data; and describes procedures to minimize missing data. Upon completion of this module, students will be able to explain why data managers should strive to minimize missing data and develop a plan to record or code why data are missing.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
KEY Points of Leicester travel clinic In London doc.docxNX Healthcare
In order to protect visitors' safety and wellbeing, Travel Clinic Leicester offers a wide range of travel-related health treatments, including individualized counseling and vaccines. Our team of medical experts specializes in getting people ready for international travel, with a particular emphasis on vaccines and health consultations to prevent travel-related illnesses. We provide a range of travel-related services, such as health concerns unique to a trip, prevention of malaria, and travel-related medical supplies. Our clinic is dedicated to providing top-notch care, keeping abreast of the most recent recommendations for vaccinations and travel health precautions. The goal of Travel Clinic Leicester is to keep you safe and well-rested no matter what kind of travel you choose—business, pleasure, or adventure.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
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International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Letter to MREC - application to conduct studyAzreen Aj
Application to conduct study on research title 'Awareness and knowledge of oral cancer and precancer among dental outpatient in Klinik Pergigian Merlimau, Melaka'
LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
The global radiation oncology market size reached US$ 8.1 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 14.5 Billion by 2032, exhibiting a growth rate (CAGR) of 6.5% during 2024-2032.
More Info:- https://www.imarcgroup.com/radiation-oncology-market
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
2. FDAAA 2007
HHS required to develop methods to access disparate
sources of electronic health information in order to monitor
the safety of medical products approved by the FDA.
Law set a goal of access to data from 25 million patients
by July 1, 2010 and 100 million patients by July 1, 2012.
Law also required FDA to work closely with partners from
public, industry and academic entities.
3. Mini Sentinel Pilot
21 collaborating entities, including America’s Health
Insurance Plans, Cigna Healthcare, Duke University School
of Medicine, several Kaiser Permanente sites, and Outcome
Sciences, Inc.
Brookings Institution served in the role as convenor,
hosting a number of open public meetings to help inform
the work of establishing the pilot and laying the foundation
for the Sentinel Initiative.
Harvard Pilgrim Healthcare served as the Operations
Center.
Privacy panel: privacy advocate, industry attorney,
4. Mini Sentinel/Sentinel Data
Architecture
Distributed Data Model: Data Partners maintain physical
and operational control over the original source data and
data are transformed into the Mini-Sentinel Common Data
Model (MSCDM) format
Operations Center sends standardized queries to Data Partners.
Data Partners execute queries against data in the MSCDM format
and share summary results with Operations Center.
Data Partners may be asked to provide non-summary, patient-
level information as follow-up, but will strip out direct patient
identifiers before disclosure to Operations Center
5. Legal Analysis
Focused on potential application of HIPAA & the Common
Rule.
Acknowledged that other medical privacy laws might
also apply (for example, Part 2 governing substance
abuse treatment data from federally assisted substance
abuse programs and state laws).
Data Partners would need to determine whether those laws
applied to their use and disclosure of health information for
Sentinel purposes.
6. HIPAA Legal Analysis
Sentinel determined to be public health use of health
information under HIPAA.
Queries to Sentinel come from the FDA pursuant to its authority
under FDAAA.
Harvard Pilgrim and Data Partners are acting under a grant of
authority from FDA; consequently, their access to health
information is also covered by the HIPAA Privacy Rule.
Although care was taken to limit FDA and Harvard Pilgrim’s
access to identifiable data, HIPAA would have permitted such
access under the public health provisions
But possible application of HIPAA minimum necessary
provisions…
7. Common Rule
OHRP determined that activities of Sentinel are not
“research” and therefore the Common Rule did not apply.
Letter provided to FDA and Harvard Pilgrim.
8. Policies Address FIPPs
Distributed data model: drug safety questions are brought to the
data
All direct identifiers are removed from information provided to the
Operations Center or the FDA
Any identifiable information received by Data Partners to confirm
drug safety signals may be used only for Mini-Sentinel purposes
Operations Center may use information it receives only for Mini-
Sentinel purposes
Operations Center manages security in accordance with the HIPAA
Security Rule and the Federal Information Security Management Act
OHRP determined that activities of Sentinel are not
9. Use of Sentinel System for
Research Data infrastructure already exists – committed data
partners, experience with MSCDM, running queries
behind their firewalls, and providing aggregate response
to Operations Center.
Could this infrastructure be deployed for research uses?
Big difference: could no longer rely on HIPAA’s public
health provisions to govern information use and
disclosure.
10. How it Could Work
Data Partners would conduct research behind their
firewalls
Necessary steps:
Determine whether or not to participate in a particular research
query.
Obtain IRB approval of research.
Consent patients or obtain IRB waiver.
Collect and/or analyze data in common data model (may need
tweaks to MSCDM to accommodate research queries).
Provide summary aggregate results to Operations Center (likely
de-identified; execute data use agreement in case of limited data
sets).
11. Issues to Consider
Retaining publicly available research data set to test
findings
Do data partners have sufficient resources to take on
conduct of research?
Will this make the research process faster or slow it
down?
12. Resources
White paper on legal basis for Sentinel:
http://mini-sentinel.org/work_products/About_Us/HIPAA_and_Co
White paper exploring potential use of Sentinel
infrastructure for clinical trials: http://www.mini-
sentinel.org/methods/methods_development/details.as
px?ID=1049